Naveh Pharma LTD/Bigdam Inc.

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites https://www.navehpharma.com/ and https://u-better.com/, and your Amazon storefront1 in March 2026. The FDA has observed that you offer your products, “RSV Hypertonic Saline 3%” and “Hypertonic Saline 7%” for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

In addition, FDA reviewed the records you submitted in response to our initial April 28, 2025, request for records and other information, and subsequent correspondence, pursuant to section 704(a)(4) of the FD&C Act for your facility, Naveh Pharma (1966) LTD, FEI 3027300316, at 19 Yad Kharutsim, Netanya, Sharon Area, Israel.

Based on a review of your websites, your “RSV Hypertonic Saline 3%” and “Hypertonic Saline 7%” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your websites that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

From the “RSV Hypertonic Saline 3%” document2 available on the webpage https://www.navehpharma.com/products/advanced-ent-line/hypertonic-saline/:

“For treatment of Bronchiolitis (RSV - respiratory syncytial virus)”

“In recent years quite a number of studies around the world, proved the effectiveness of treatment with Hypertonic saline inhalation in infants hospitalized suffering from acute bronchiolitis.”

“Hypertonic saline inhalation therapy resulted in clinical improvement and shortening the duration of hospitalization.”

“Hypertonic saline works by raising fluid lining in the airway walls, reducing the edema layer of the submucosa, improving Rheological properties of sputum and acceleration of the mucus clearance (MC).”

“For respiratory use with inhalators in cases of bronchiolitis- RSV infections”

On the webpage https://u-better.com/products/saline-solution-3-for-daily-inhalation-25-vials:

“This 3% saline solution is ideal for nebulizer therapy and nasal irrigation. It helps clear mucus and supports easier breathing.”

“Gentle On Airways And Clinically Sterile Saline (NaCl + water) That Helps Loosen Mucus and Hydrate Nasal & Respiratory Passages—For Clear, Comfortable Breathing.”

The product name: “RSV Hypertonic Saline”

On the webpage https://www.navehpharma.com/products/advanced-ent-line/hypertonic-saline-7/:

“Hypertonic saline creates an osmotic pressure that increases the volume of airway surface liquid, restore mucus clearance, and improve lung function.”

“Recent clinical studies in patients with cystic fibrosis, have shown that inhalation of hypertonic saline produced a sustained acceleration of mucus clearance and improved lung function. This treatment improves sputum viscosity and ease expectoration.”

“The advantages of treatment with 7% hypertonic saline in lung diseases are:o Improving lung functiono Stimulate mucociliary clearanceo Improving quality of lifeo Decreases hospital admissions. . .o Effective treatment of moderately and severe lung diseases.”On the webpage https://u-better.com/products/saline-solution-7-for-respiratory-relief-25-vials

“This 7% saline solution is a powerful option for respiratory support, ideal for clearing mucus and promoting easier breathing. Designed for inhalation and nasal irrigation, it’s perfect for adults and seniors managing respiratory health.”

Your “RSV Hypertonic Saline 3%” and “Hypertonic Saline 7%” products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a))

The records and information you submitted stated that your firm does not have a quality unit (QU) to provide adequate quality oversight over the manufacture and release of finished drug products shipped to the United States.

Without an established quality unit, your facility lacks an effective quality system. See FDA’s guidance document ICH Q10 Pharmaceutical Quality System, as well as Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71553/download, and https://www.fda.gov/media/71023/download, respectively.

In response to this letter, provide the following:

A comprehensive assessment and remediation plan to ensure you establish a QU that is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier 724669 in the subject line of the email.